Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission

NCT01349569 | Completed Phase 2 Results DMC

• 2 other identifiers: J1115NA_00044463
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to find out if the investigators can improve outcomes for multiple myeloma patients by giving a myeloma vaccine to patients who are already on lenalidomide (Revlimid) and in a near complete remission.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Response Conversion Rate

  Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, \< 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells.

  Up to 1 year

Secondary Outcomes (4)

• Time to Response

  Up to 4 years

• Effect on Clonogenic Myeloma Precursors

  Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year

• Grade 3-4 Toxicity

  Up to 1 year

• Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells

  Baseline, Cycle 3 Day 14, end of study (up to 1 year)

Study Arms (1)

Myeloma Vaccine, Prevnar, & Lenalidomide

EXPERIMENTAL

Lenalidomide will be continued on the same dose as was being administered prior to the study. The allogeneic myeloma vaccine and Prevnar-13 vaccine will be given on four days over the course of the study.

Drug: Lenalidomide; Biological: Allogeneic Myeloma Vaccine; Biological: Prevnar-13

Interventions

Lenalidomide DRUG

Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Also known as: Revlimid

Myeloma Vaccine, Prevnar, & Lenalidomide

Allogeneic Myeloma Vaccine BIOLOGICAL

A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Myeloma Vaccine, Prevnar, & Lenalidomide

Prevnar-13 BIOLOGICAL

Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Also known as: Pneumococcal 13-Valent Conjugate Vaccine

Myeloma Vaccine, Prevnar, & Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Myeloma eligibility criteria are the following:
• sustained near complete remission (nCR) for 4 months defined as no measurable M-spike and a positive immunofixation
• early biochemical relapse as manifest by going from a true CR (immunofixation negative) to a nCR (immunofixation positive) at any time
• conversion from a nCR to the appearance of a monoclonal spike in the serum not greater than 0.3mg/dL
• age 18 years and older
• Eastern Cooperative Oncology Group performance scores 0-2
• History of measurable serum or urine M protein or free light chains
• Life expectancy greater than 12 months
• Corrected serum calcium \< 11 mg/dL, and no evidence of symptomatic hypercalcemia
• Serum creatinine\< 2
• Absolute Neutrophil Count \>1000
• Platelet \>100,000
• Total bilirubin less than or equal to 1.5 x Upper limit of normal
• Aspartate aminotransferase and Alanine transaminase less than or equal to 3 x Upper limit of normal
• Negative pregnancy test if applicable

You may not qualify if:

• Disease progression after stopping corticosteroids as defined as the appearance of an M-spike \>0.5g/dL
• Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, non-secretory myeloma and amyloidosis.
• HIV disease, active infection requiring treatment with antibiotics, anti-fungal or anti-viral agents within 2 weeks of enrollment would be excluded from the study.
• Patients who have participated in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug.
• History of an active malignancy other than myeloma
• Autoimmune disease requiring active treatment.
• Known contra-indication to any component of Prevnar 13 including the diphtheria toxoid-containing vaccine.
• History of latex allergy
• History of an autologous stem cell transplant within the past 12 months or less
• History of an allogeneic transplant

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Celgene Corporation: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Ivan Borrello, MD
• Organization: Johns Hopkins University

iborrell@jhmi.edu

4109554967

Study Officials

• Ivan Borrello, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 6, 2011
• Study Start: January 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)